FDA Fellowship in Development and Control of Cell Free Manufacturing Platform Technologies

Oak Ridge Institute for Science and Education; Silver Spring (MD); On-site; USD 55,000 - 70,000; Full time

Job summary

Oak Ridge Institute for Science and Education invites applications for a research opportunity with the FDA CDER in Silver Spring, MD. The role focuses on cell-free protein synthesis using mammalian and prokaryotic extracts, aiming to establish robust CMAs and analytical procedures to ensure product quality in biomanufacturing.

The appointment is full-time and funded for one year, with a rolling review process. Applicants should be U.S.

Qualifications

• Currently pursuing or hold a doctoral degree in a relevant field, with degree received within the last 60 months.
• U.S. citizenship required.
• Experience with CFPS platforms and analytical assays preferred.
• Experience with protein purification and analytical characterization preferred.

Responsibilities

• Engage in hands-on CFPS experiments under mentor guidance.
• Develop analytical assays to characterize CMAs and monitor quality.
• Present research findings at internal FDA meetings and draft manuscript for publication.
• Attend regular mentor meetings to discuss progress and regulatory context.

Skills

Cell-free protein synthesis (CFPS)

Recombinant protein engineering

Protein aggregation dynamics

Analytical purification/assays

Education

Doctoral degree

Job description

Reference Code

FDA-CDER-2026-0174

Application Deadline

3/31/2027 12:00:00 AM Eastern Time Zone

Contact

If you have questions, send an email to [e-mail]. Please include the reference code for this opportunity in your email.

Description

Applications will be reviewed on a rolling-basis.

FDA Office and Location

A research opportunity is available immediately with the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) located in Silver Spring, Maryland.

Research Project

Under the guidance of a mentor, you will engage in a hands‑on learning experience involving Cell‑free protein synthesis (CFPS) utilizing mammalian and prokaryotic extracts. This is a developing manufacturing technology that enables the rapid, decentralized, and on‑demand production of life‑saving therapeutics and medical countermeasures. However, the lack of standardized quality control assays and the inherent batch‑to‑batch variability of the biological raw materials pose significant regulatory challenges for broader implementation. Currently, there is a gap in establishing a robust Chemistry, Manufacturing, and Controls (CMC) framework to ensure the consistent quality of products derived from these diverse platforms. We propose to develop cell free manufacturing platform technology and validate robust analytical procedures to characterize the critical material attributes (CMAs) of both mammalian (e.g., CHO, HeLa) and prokaryotic (e.g., E. coli) cell extracts to systematically assess their viability and reproducibility for safe and effective biomanufacturing.

Research Initiatives

Improve or advance science‑based quality standards and manufacturing practices to assure product quality, safety, and efficacy & identify, evaluate, and understand emerging product, manufacturing, and analytical testing technologies to aid in risk‑based quality assessment and support standards, policy and guidance development.

Research Activities

• Execution of mammalian and prokaryotic cell‑free protein synthesis reactions, actively developing and qualifying analytical assays (e.g., fluorometric assays, HPLC, ceSDS) to monitor extract productivity, batch‑to‑batch variability, and overall protein quality.
• Weekly meetings with mentor to assess progress and provide targeted training, review experimental data, and discuss how the data applies to current CMC regulatory frameworks.
• Training on how to deliver research findings to a scientific audience by presenting at internal FDA meetings and actively participating in the drafting of a manuscript for a peer‑reviewed scientific journal.
• Biweekly meetings to learn scientific knowledge in a variety of disciplines.

Learning Objectives

You will gain and advance your current scientific skill set in cutting‑edge biomanufacturing and analytical characterization. Additionally, you will learn how to interpret complex scientific data, perform advanced laboratory techniques, and apply ICH guidelines to experimental design. You will also learn how to communicate research findings effectively, bridging the gap between bench science and regulatory policy. Your training and acquired skill set will have applicability across scientific disciplines to ensure you have the opportunity to choose different career paths in academia, industry, or the federal government.

During This Appointment, You Will

• Receive hands‑on training in advanced analytical techniques and cell‑free biomanufacturing workflows (spanning both prokaryotic and mammalian systems) to advance your technical skillset.
• Improve scientific knowledge regarding FDA regulatory science, Quality by Design (QbD), and CMC requirements.
• Learn about laboratory‑scale extract production, qualification, and protein synthesis.
• Improve scientific communication during presentation construction and the delivery of research findings to a regulatory audience.
• Learn presentation skills and training in scientific manuscript drafting.
• Support your scientific career pursuit by attending weekly meetings with a group of seasoned scientists, at which they you will present your research and integrate your findings into a variety of scientific and regulatory disciplines.

Mentor

The mentor for this opportunity is Thomas Biel ([e-mail]). If you have questions about the nature of the research, please contact the mentor.

Anticipated Appointment Start Date

October 2026. Start date is flexible and will depend on a variety of factors.

Appointment Length

The appointment will initially be for one year, but may be renewed upon recommendation of FDA and is contingent on the availability of funds.

Level of Participation

The appointment is full time.

Participant Stipend

The participant will receive a monthly stipend commensurate with educational level and experience.

Citizenship Requirements

This opportunity is available to U.S. citizens only.

Education

• Non‑employee nature of the ORISE appointment;
• Prohibition on ORISE Fellows performing inherently governmental functions;
• Obligation of ORISE Fellows to convey all necessary rights to the FDA regarding intellectual property conceived or first reduced to practice during their fellowship;
• The fact that research materials and laboratory notebooks are the property of the FDA;
• ORISE fellow’s obligation to protect and not to further disclose or use non‑public information.

Qualifications

The qualified candidate should be currently pursuing or have received a doctoral degree in the one of the relevant fields. Degree must have been received within the past five years.

Preferred Skills

• Hands‑on experience with cell‑free protein synthesis (CFPS) platforms and protocols.
• Familiarity with recombinant protein engineering and biomanufacturing scale‑up.
• Experience analyzing protein aggregation dynamics and nuclease activity (e.g., DNase, RNase, micrococcal nuclease).
• Experience in standard protein purification and analytical assays.

Eligibility Requirements

Citizenship: U.S. Citizen Only

Degree: Doctoral Degree received within the last 60 months or currently pursuing.

Discipline(s):

• Engineering
  • Bioengineering and Biomedical Engineering
  • Biological/Biosystems Engineering
  • Chemical Engineering
• Life Health and Medical Sciences (6 )

Affirmation

I am a U.S. citizen, or I have lived in the United States for at least 36 out of the past 60 months. (36 months do not have to be consecutive.)

and

I have read the FDA Ethics Requirements.

Point of Contact

Ashley